Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-50
SponsorUniversity Hospital, Tours

About this trial

The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 2 and 12 years

Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11

Group of children without TND : Age between 0 and 12 years

Disqualifiers

Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD

Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2

Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)

Trial design

Design model

Parallel

Treatments tested in this trial

  • eye-tracker

    Other intervention

    Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

Treatment groups

460 Participants
are divided into 5 treatment groups
Group A: Group of adult subjects without ASD (Autism Spectrum Disorders)Other 1 intervention
Group B: Group of children without ASDOther 1 intervention
Group C: Group of children with ASDOther 1 intervention
Group D: Group of children without NDD (NeuroDevelopmental Disorders)Other 1 intervention
Group E: Group of children with NDD, or whose diagnosis is in progressOther 1 intervention

Trial outcomes

Primary outcomes

1

Oculometric measurements 1: Tracking time

Mean of tracking time (ms) during entire stimuli duration

Time frame
through study completion, an average of 1 year (first phase) and of 2 years (second phase)
2

Oculometric measurements 2: Fixation time on the screen

Mean of fixation time on the screen (ms) during entire stimuli duration

Time frame
through study completion, an average of 1 year (first phase) and of 2 years (second phase)
3

Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration

Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration

Time frame
through study completion, an average of 1 year (first phase) and of 2 years (second phase)
4

Oculometric measurements 4: Fixation time on the mouth area of face stimuli

Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration

Time frame
through study completion, an average of 1 year (first phase) and of 2 years (second phase)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Collaborator

Laboratory of Fundamental and Applied Computer Science of Tours, EA6300

Collaborator

National Research Agency, France

Collaborator

Ministry of Health, France

Collaborator